APPLICATION
ANDA217480
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-15
LATEST ACTION
2025-04-16
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
GADOBUTROLPrescription
GADOBUTROL 18.1416GM/30ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADOBUTROLPrescription
GADOBUTROL 1.20944GM/2ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADOBUTROLPrescription
GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADOBUTROLPrescription
GADOBUTROL 39.3068GM/65ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADOBUTROLPrescription
GADOBUTROL 6.0472GM/10ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADOBUTROLPrescription
GADOBUTROL 9.0708GM/15ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2025-04-16Manufacturing (CMC) · Supplement 4 · unknownAP
2023-03-15UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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